Investigation of the effect of misoprostol alone in comparison with misoprostol with Foley catheter on cervical ripening for labor induction in women with preterm premature rupture of the membrane
Determination of the effect of misoprostol alone in comparison with misoprostol with Foley catheter on cervical ripening for labor induction in women with preterm premature rupture of the membranes
Design
This study is a randomized clinical trial conducted on 200 women with PPRM. Patients are randomly assigned to either misoprostol or misoprostol with a Foley catheter group based on the randomly generated list.
Settings and conduct
This study takes place in Ghaem and Omol-Banin hospitals without blinding. Therapeutic measures are carried out in both groups and finally, the interval between the onset of the intervention and delivery, in both groups are measured and compared. Patients are followed up through phone calls for 2 weeks in terms of incidence of febrile complications such as metritis, episiotomy and incision-site infection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: alive singleton pregnancy, gestational age is greater than or equal to 36 weeks
Exclusion criteria: symptoms of chorioamnionitis in mother or fetus at the onset of hospitalization, gestational Diabetes, fetal distress, previous cesarean section, active labor phase
Intervention groups
Control group: Immediately after admission, labor induction with 25 μg sublingual misoprostol is performed every 4 hours for patients.
Intervention group: :Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours with insertion of foley catheter size 18 and filling the balloon with 80 cc of normal saline, which is placed in dorsal lithotomy position in sterile conditions.
Misoprostol is prescribed up to 4 doses in case of need.
Main outcome variables
The interval between the onset of induction and delivery; the delivery method; frequency of vaginal examinations; incidence of tachysystole; chorioamnionitis; the duration of administration of oxytocin and the infant's 1 and 5-minute apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181123041731N1
Registration date:2019-01-27, 1397/11/07
Registration timing:registered_while_recruiting
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Malihe Rakhshani Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2861
Email address
rakhshanifm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of misoprostol alone in comparison with misoprostol with Foley catheter on cervical ripening for labor induction in women with preterm premature rupture of the membrane
Public title
Investigation of the effect of misoprostol in comparison with misoprostol with Foley catheter on cervical ripening for labor induction of in women with preterm premature rupture of the membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Alive singleton pregnancy
Gestational age is greater than or equal to 36 weeks
Cephalic presentation
Bishop Score is less than 4
Exclusion criteria:
Symptoms of chorioamnionitis in mother or fetus at the onset of hospitalization
Gestational Diabetes
Fetal distress
Previous cesarean section and any contraindication for vaginal delivery
Time of membrane rupture exceeds 12 hours
Active labor phase
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment is based on the random list generated by a computer. At first, two series with equal numbers of green and blue cards are prepared and placed into envelopes which are numbered according to the random list. Afterwards, the midwife assigns an envelope to each patient based on the numerical order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-12-29, 1395/10/09
Ethics committee reference number
IR.MUMS.fm.REC.1395.490
Health conditions studied
1
Description of health condition studied
Preterm premature rupture of the membranes
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
time interval between the onset of induction and delivery
Timepoint
after intervention
Method of measurement
Patient's file
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours for patients after hospitalization. Misoprostol is prescribed up to 4 doses in case of need.
Category
Treatment - Drugs
2
Description
Intervention group:Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours with insertion of foley catheter size 18 and filling the balloon with 80 cc of normal saline, which is placed in dorsal lithotomy position in sterile conditions. In addition, light stretching is performed in order to examine the catheter exit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommol-Banin hospital
Full name of responsible person
Masoumeh Mirteimouri
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Malihe Rakhshani Far
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Rakhshanifm951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Rakhshani far
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
rakhshanifm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Rakhshani Far
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Rakhshanifm951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.